Why You Should Attend

Are you looking for an interactive refresher on the structure and content of the CTD and application routes specifically designed for QA professionals? Look no further.

This workshop includes real examples of regulatory procedures and data requirements for MAA/NDA submissions in the EU/USA and other world markets. It is also relevant to medicinal products containing small molecule drug substances, biologics, generics and biosimilars, drug device combinations and borderline products.

This workshop will explore:

Regulatory agency expectations on the data that should be included in an e-CTD

What can (and often) does go wrong when too much/the wrong information is registered

The role of the QP/QA in managing what is registered

New/emerging CMC requirements – what’s coming up?

By the End of This Workshop, You Will Improve/Expand…

Your awareness and knowledge of the latest regulatory procedures and CMC requirements for major market submissions

Your knowledge on how different regulatory procedures work

Your understanding of some of the differences between EU and US CMC requirements.

Your ability to communicate with your regulatory support functions

Facilitated By…

Helen Erwood

Helen has been working in pharmaceutical regulatory affairs/regulatory compliance for many years; she has wide experience in the regulation of medicines, medical devices and borderline/OTC/ nanotechnology products and enjoys the challenge of dealing with something that doesn’t quite fit the current regulations. Helen is also eligible to act as a nonclinical expert for EU submissions. In addition, Helen also regularly presents at The Organisation for Professionals in Regulatory Affairs (TOPRA) meetings and provides training within the industry on regulatory affairs.

Workshop Fees

Workshop cost (excluding VAT) £710.00

DISCOUNTS AVAILABLE

Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities - contact us for details.

Have a question or want to book a place? Contact pharmacourses@nsf.org - you can also register online by clicking below.